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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 020 Date of Entry 09/09/2008 
FR Recognition Number 13-22
Standard
CLSI  LIS07-A
Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
Scope/Abstract
This specification identifies the way bar coded sample identification labels are applied to clinical specimen containers. It documents the form, placement, and content of bar code labels on specimen tubes that are used on clinical laboratory analyzers. It enables Laboratory Information System vendors to produce reliable bar coded symbols that are readable by any complying clinical laboratory analyzer vendor.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.2100 Calculator/Data Processing Module, For Clinical Use Class 1 JQP
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Yan Zhang
  CDRH/OPEQ/OHTVII/DMGP/MGB/
  301-837-7386
  yan.zhang1@fda.hhs.gov
 Thomas Miller
  CDRH/OPEQ/OHTVII/DCTD/CB/
  240-402-8938
  Thomas.Miller@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Groups (STG)
Software/Informatics (primary)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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